Great Saphenous Vein Anatomy at the Proximal Medial Thigh... | NCT04922606

Studies
Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access

NCT04922606

Sponsor

Mayo Clinic

Status

Enrolling by invitation

Last Update Posted

Jul 11, 2025Actual

Enrollment

190Estimated

Phase

Not Applicable

Conditions

Anatomy of the GSV for Rescue Peripheral IV Access

Interventions

US ot the GSV

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2021Actual

Primary Completion Date

May 2045Estimated

Completion Date

May 2045Estimated

First Submitted Date

May 7, 2021

First Submission Date that Met QC Criteria

Jun 8, 2021

First Posted Date

Jun 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2025

Last Update Posted Date

Jul 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the anatomy of the great saphenous vein at the level of the medial thigh in the general population in an effort to categorize this as a reliable target vessel for rescue peripheral IV access.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
US of GSV	Other	Ultrasound of the Great Saphenous Vein	Diagnostic Test: US ot the GSV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
US ot the GSV	Diagnostic Test	Ultrasound of the Great Saphenous Vein	US of GSV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful visualization of GSV	Number of times the great saphenous vein is identified at the level of the medial distal thigh in the general population using ultrasound	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Pediatric and adult Emergency Department patients and employees of all ages from all areas of the emergency department or additional training sites staffed by emergency medicine residents.

Exclusion Criteria:

Critically ill patients as determined by the Emergency Medicine consultant of record for the patient.
Legs not accessible due to dressing, wounds, or other factors.
Overlying cellulitis/soft tissue infection or injury.
Patients that are prison inmates and patients/patient's surrogates who are unable to give verbal consent/assent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Kummer, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided